复方益母胶囊质量标准提高研究  

Improvement of the Quality Standard of Fufang Yimu Capsule

作　　者：李柯[1] 陈丹 李若存[1] 蒋波[1] 林凡友 王文天 Li Ke Chen Dan Li Ruocun Jiang Bo Lin Fanyou Wang Wentian(Hunan Academy of TCM, Changsha, Hunan, China 410013 Xiangtan Medical and Health Vocational and Technical College, Xiangtan, Hunan, China 411102 Xiangyu Pharmaceutical Limited by Share Ltd., Linyi, Shangdong, China 276023)

机构地区：[1]湖南省中医药研究院,湖南长沙410013 [2]湘潭医卫职业技术学院,湖南湘潭411102 [3]翔宇药业股份有限公司,山东临沂276023

出　　处：《中国药业》2017年第15期16-19,共4页China Pharmaceuticals

摘　　要：目的提高复方益母胶囊质量标准。方法采用薄层色谱(TLC)法对复方益母胶囊中益母草进行定性鉴别;采用高效液相色谱法进行定量分析,色谱柱为Hypersil NH_2柱(250 mm×4.6 mm,5μm),流动相为磷酸盐缓冲液(p H=5.5)-乙腈(20∶80),检测波长为192 nm。结果 TLC斑点清晰,分离效果好,阴性对照无干扰;盐酸水苏碱质量浓度在0.027~0.162 g/L范围内与峰面积线性关系较好(r=0.999 5),平均回收率为97.58%,RSD为2.82%(n=9)。结论所建立的定性、定量分析方法可用于复方益母胶囊的质量控制。Objective To improve the quality control standard of Fufang Yimu Capsule.Methods TLC was used for identification of Leonuri Herba in Fufang Yimu Capsule.HPLC was used for quantitative analysis.The Hypersil NH2 column（250 mm × 4.6 mm,5 μm）was used with the mobile phase of mixture of phosphate buffer-acetonitrile（pH = 5.5,20 ∶ 80）,the detection wavelength was 192 nm.Results TLC sports developed were fairy clear,and the blank test showed no interference.The linear relationship of stachydrine hydrochloride was good in the range of 0.027-0.162 g/L（r = 0.999 5）.The average recovery rate was 97.58%,RSD = 2.82%（n = 9）.Conclusion The established qualitative and quantitative analysis method is applicable for the quality control of Fufang Yimu Capsule.

关 键 词：复方益母胶囊 质量标准 高效液相色谱法 盐酸水苏碱 

分 类 号：R284.1[医药卫生—中药学]